Drug and pharmaceutical recalls
17625 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-243-01
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-242-01
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-242-02
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-03
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-05.
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-04
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-06
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-239-01
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-01
Subpotent Drug
- 2017-11-01FDA-DrugPharmedium Services, LLCClass IIOxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-03
Subpotent Drug
- 2017-11-01FDA-DrugAbbVie Inc.Class IIIAndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
- 2017-11-01FDA-DrugAbbVie Inc.Class IIIAndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
- 2017-11-01FDA-DrugVitilityClass IMAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; vitility@yahoo.com; www.manofsteelpills.com; UPC 1 0001001378 7.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
- 2017-11-01FDA-DrugLucky Mart Inc.Class IPIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, Manufactured By: Jimin Pharmaceutial Co., LTD., Distributor: Lucky Mart, El Monte, CA 91733, NDC 68085-8012-4.
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
- 2017-11-01FDA-DrugBaxter Healthcare CorporationClass IIntralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
- 2017-11-01FDA-DrugBecton Dickinson & CompanyClass IIChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IINorepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025014801
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIVANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025007001
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIVANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025002501
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IISuccinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025088801
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIRopivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIOXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025000101
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IINorepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011501
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIMidazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025016201
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIMagnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025003201
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIHydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001.
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIfentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011001
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIfentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025011001
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025024801
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIDiltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601
Lack of Assurance of Sterility.
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